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CompletedNCT03087877Updated Dec 31, 2018

Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor

An interventional study of Acetaminophen Challenge (G6 CGM) in Diabetes Mellitus, sponsored by DexCom, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-31.

Sponsored by DexCom, Inc. · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was Mar 2017, 9 years 7 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.

Read the detailed description

The interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the G6 CGM system after administration of acetaminophen. Bias will be evaluated by comparing CGM values to a laboratory referenceusing venous sample measurements.

02

Conditions studied

  • Diabetes Mellitus
03

In context

Lead sponsor

DexCom, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ages 18 or older
  • Diagnosis of diabetes

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Known gastroparesis
  • Abnormal liver function
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Other
    CGM Users

    Prospective, non-randomized, single-arm. Continuous Glucose Monitoring. Acetaminophen challenge is the intervention.

    Device: Acetaminophen Challenge (G6 CGM)

Interventions

  • DeviceAcetaminophen Challenge (G6 CGM)

    Evaluation of acetaminophen effect on CGM glucose sensing

06

What researchers measure

Primary outcomes

  1. Interference Effect for the G6 CGM

    Bias of sensor to reference measurement pre and post acetaminophen administration

    Time frame: 6 hrs post dose

Secondary outcomes

  1. Mean of sensor minus YSI values (bias) for various time periods

    Bias calculated for pre-dose, post dose and peak post dose

    Time frame: 6 hrs post dose

  2. Duration of interference effect for the G6 CGM

    Length of time the inhibition effect is more than 10 mg/dL

    Time frame: 6 hrs post dose

07

Study locations

4 sites
  • AMCR
    Escondido, California 92025, United States
  • William Sansum Diabetes Center
    Santa Barbara, California 93105, United States
  • Diablo Clinical Research
    Walnut Creek, California 94598, United States
  • Rainier Clinical Research Center Inc
    Renton, Washington 98057, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03087877
Lead sponsor
DexCom, Inc.
Responsible party
Sponsor
First posted
Mar 23, 2017
Start date
Feb 3, 2017
Primary completion
Mar 4, 2017
Completion
Mar 4, 2017
Last update
Dec 31, 2018

Study contacts

David Price, MD
study director · DexCom, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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